Doxycycline Hyclate (Page 4 of 4)

HOW SUPPLIED

Doxycycline hyclate tablets, USP equivalent to 100 mg of doxycycline: Beige color, round convex, film coated tablets debossed “312” below, “B” on one side and plain on the other.

Bottles of 50 tablets NDC 42806-312-50

Bottles of 100 tablets NDC 42806-312-01

Bottles of 500 tablets NDC 42806-312-05

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY

Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4 , and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4 , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.

Minocycline, tetracycline PO4 , methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

REFERENCES

1.
Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149–195.
2.
Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524–528.
3.
Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315–317.
4.
Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225–226.

Distributed by:

Epic Pharma, LLC

Laurelton, NY 11413 USA

Product of USA

Rev.01-2019-00

MF312REV01/19

BP0089-02

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg, 50 Tablets

Epic Doxycycline Hyclate Tablets, USP

100 mg 50 Tablets

Rx Only

Doxy Epic 100 mg 50ct
(click image for full-size original)
DOXYCYCLINE HYCLATE
doxycycline hyclate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-312
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
POLYSORBATE 80
FD&C BLUE NO. 2
Product Characteristics
Color BROWN (BEIGE) Score no score
Shape ROUND (convex) Size 9mm
Flavor Imprint Code 312;B
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42806-312-50 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:42806-312-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:42806-312-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062269 10/01/2016
Labeler — Epic Pharma, LLC (827915443)
Registrant — Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe (080230346)
Establishment
Name Address ID/FEI Operations
Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe 080230346 MANUFACTURE (42806-312)

Revised: 07/2020 Epic Pharma, LLC

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